Pharmacokinetics and -dynamics of needlefree apomorphine administration vs. subcutaneous injections with apomorphine in patients with Parkinson*s disease; a pilot study with a new device

Pharmacokinetics and -dynamics of needlefree apomorphine administration vs. subcutaneous injections with apomorphine in patients with Parkinson*s disease; a pilot study with a new device - Pharmacokinetics and -dynamics of needlefree apomorphine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35723

Enrollment

Registered

2011-11-14

Start date

2011-11-23

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

The intervention is the administration of apomorphine via the needlefree system. The Apo-go penject administration serves as a comparator, as this is the standard method of administration of apomorp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosed Parkinson's Disease according to UK brain bank criteria;Current usage of Apo-go injector;Not satisfied with the current injection pen

Exclusion criteria

Exclusion criteria: Participation in other trials;Dependent on dopaminergic medication at night;Severe cognitive pathology, making it difficult to understand the study procedures

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters of apomorphine (measured at t=0, 3,6,9,12,15,20,30,45,60,90 minutes) - Absorption/elimination halflifes, AUC, Cmax and Tmax. - Concentration-effect relationship of the NAS vs. Apo-go	—

Secondary

Measure	Time frame
Timed Up and Go test AE questionnaire Qualitative Erythema Scale Minolta erythema assessment 5-point Satisfaction Scale	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)